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Tuesday, April 2, 2013

The Novartis
decision raises several fundamental questions which quite a few of us have
been pondering over for quite some time. For instance, the need for and relevance
of definition of “new invention” in Section 2(1)(ta) of the Act. If the definition
of invention under Section 2(1)(j) already refers to a “new product or process”
which is then governed by “Anticipation” in Chapter VI, where is the need for
another term called “new invention”? I’d be grateful if readers could point out
any section or rule of the Patents Act other than Section 2(1)(ta) which uses the term “new invention”.

The Supreme Court has attempted
to address some of these issues in its decision. For instance, in Paras 25 and 26, the Court asks thus:

“25. Some important provisions of the Patents Act, 1970, as they stand
after the amendment of the Act in 2005, and with which we are especially
concerned in this case, indeed present a problem of interpretation. Why was
section 5, which, in one sense, was the distinctive feature of the patent law
in India, taken off the statute book? What does the legislature wish to say
through clauses (j) and (ja) of section 2(1), section 3 and several other
sections? How is it that some of the provisions of the Act apparently seem to
be of no use or purpose, e.g., sections 2(1)(l) and 2(1)(ta)? Why is it that
some of the crucial provisions in the Act appear to be wanting in precision and
clarity?

26. It is easy to know why section 5 was deleted but to understand the
import of the amendments in clauses (j) and (ja) of section 2(1) and the
amendments in section 3 it is necessary to find out the concerns of Parliament,
based on the history of the patent law in the country, when it made such basic
changes in the Patents Act. What were the issues the legislature was trying to
address? What was the mischief Parliament wanted to check and what were the
objects it intended to achieve through these amendments?”

Though these questions were
raised in Page 14 of the decision, the Hon’ble Court goes on to discuss the
entire history of the Indian Patent regime and its tryst with TRIPS until Para
86@Page 50....It is only again in Para 87 that the Court returns to the issue
of “invention” and “inventive step”.

“Therefore, inventive
step does not refer solely to a “non-obvious technical advance”, but in fact
refers to a “non-obvious feature” which involves either a technical advance or
has economic significance or both.

...

The other important
corollary is that the presence of technical advance is not the sole criterion
to judge if an invention has an inventive step. Economic significance of a
feature which is non-obvious too by itself could help the product or the
process satisfy the “inventive step” requirement. Importantly, the criterion of
economic significance is equally applicable to products and processes.”

Following is what the Supreme
Court has held in Para 90@Page 52 of its decision:

“90. On a combined reading of causes (j), (ac) and (ja) of section 2(1),
in order to qualify as “invention”, a product must, therefore, satisfy the
following tests:

(i) It must be “new”;

(ii) It must be “capable of being made or used in an industry”

(iii) It must come into being as a result of an invention which has a
feature that:

(a) entails technical advance over existing
knowledge;

Or

(b)has an economic significance

And

(c) makes the invention not obvious to a person skilled in the art.”

Clearly, according to the Supreme
Court, a feature which has an economic significance, which feature also makes
the invention non-obvious qualifies as “inventive step” under the Patents Act. In
other words, it is not just technical advance that qualifies as “inventive step”.
The “or” in the definition is meant to distinguish between “technical advance”
and “economic significance”. That settles the issue for good...

Relationship Between Section 2(1)(j) and Section 3: “Invention” and “Patentability”

The Supreme Court, in Paras 91
and 92, has taken the view that “invention” and “patentability” are two distinct
requirements that a patent application has to satisfy for grant of a patent.
The Court has noted that “Something may
be an “invention” as the term is generally understood and yet it may not qualify
as an “invention” for the purposes of the Act. Further, something may even
qualify as an “invention” as defined under the Act and yet may be denied patent
for other larger considerations as may be stipulated in the Act.”

With specific reference to the
nature of proscriptions under Section 3, the Court observed in Para 92 that “section
3, it puts at one place provisions of two different kinds: one that declares that
certain things shall not be deemed to be “inventions” [for instance clauses (d)
& (e)];and the
other that provides that, though resulting from invention, something may yet
not be granted patent for other considerations [for instance clause (b)]”

Again in Para 181, the Court took
the following view:

“181. While dealing with the explanation it must also be kept in mind
that each of the different forms mentioned in the explanation have some
properties inherent to that form, e.g., solubility to a salt and hygroscopicity
to a polymorph. These forms, unless
they differ significantly in property with regard to efficacy, are expressly
excluded from the definition of “invention”.....(continued)”

In other words, if the subject-matter
of a patent application fails to overcome the requirement of Section 3(d), it
is not an invention within the meaning of the Act under Section 2(1)(j). Therefore,
at least with respect to pharmaceutical substance, Section 3(d) must be used as
the first filter before the subject-matter is tested on the anvils of Section
2(1)(j). This was exactly the view taken by the IPAB
in the Yahoo decision on Section 3(k), which was as follows:

“Finally
we come to the ground of non-patentability under S. 3 (k). If the claimed
subject matter is not an invention or if the invention is not patentable or if
it is excluded by S.3 of the Act, then none of the other objections need to be
considered.Only if the
claimed subject matter is a patentable invention we need to look at
anticipation, obviousness etc.”

It is another matter that the
IPAB itself was inconsistent in the application of this logic in the very same
Yahoo decision...

Similarly, in the Novartis
decision, having stated clearly in Para 181 that forms of a chemical substance
which do not exhibit significantly different efficacy characteristics are “expressly
excluded from the definition of invention”, the Supreme Court again
blurs this position by stating as follows in Para 192 (read with Para 104):

“192. Section 2(1)(j) defines “invention” to mean, “a new product or …”,
but the new product in chemicals and especially pharmaceuticals may not
necessarily mean something altogether new or completely unfamiliar or strange
or not existing before. It may mean something “different from a recent
previous” or “one regarded as better than what went before” or “in addition to
another or others of the same kind”. However, in case of chemicals and
especially pharmaceuticals if the product for which patent protection is claimed
is a new form of a known substance with known efficacy, then the subject
product must pass, in addition to
clauses (j) and (ja) of section 2(1), the test of enhanced efficacy as provided
in section 3(d) read with its explanation”

The above-underscored line gives
room for some to say that only after the claimed subject-matter is tested under
Section 2(1)(j) and (ja), it must be additionally scrutinized under Section 3(d).
In the absence of the above statement, it would have been possible to test the
invention first for satisfaction of Section 3(d), and if it failed to overcome
the provision, there would be no further need to examine it under Section
2(1)(ja). This would have been better since a Section 3(d) analysis, by its
very nature, entails a check for novelty as well.

It remains to be seen how the
Patent Office and the IPAB interpret and apply the decision of the Supreme
Court in this regard to pharma and chemical applications henceforth.

1 comment:

Sections 3d of Indian Patent Act has been widely discussed after Novartis Case however the main focus remains on the first part of the Section that is the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy. This Section has three parts and the first part is centre point of appraisal and discussion. The next part says about new use for a known substance. Then there comes the last and loosely drafted part of the Section which states that the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. If we break it into parts and then interpret it the flaw is apparent. Can mere use of a known machine or apparatus employ a new reactant? This looks absurd and the person drafted the Section seems to have little or no knowledge of Science or Chemistry. This Section needs to be redrafted as given under:“the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance, machine or apparatus or of the mere use of a known process unless such known process results in a new product or employs at least one new reactant.”